Catalog Number

60513

Brand Name

AVANOS

Version/Model Number

92755

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FDI

Product Code Name

SNARE, FLEXIBLE

Public Device Record Key

9b9cd3d8-4a0e-4067-bffd-024463889b7d

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

July 27, 2019

Package DI Number

10350770927555

Quantity per Package

10

Contains DI Package

00350770927558

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA